NCT02257983 is a Phase 2 clinical trial of EPI-743 in Noise-induced Hearing Loss, sponsored by Edison Pharmaceuticals Inc.

Who is sponsoring NCT02257983?

NCT02257983 is sponsored by Edison Pharmaceuticals Inc.

What drugs are being tested in NCT02257983?

Interventions in NCT02257983: EPI-743, Placebo.

What condition does NCT02257983 study?

NCT02257983 studies Noise-induced Hearing Loss.

Is NCT02257983 still recruiting?

NCT02257983 is currently completed. Last updated 18 November 2020.

Last reviewed 2020-11-18 · How we verify

NCT02257983

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Protective Effects of EPI-743 on Noise-Induced Hearing Loss

Completed Phase 2 Last updated 18 November 2020

What this trial tests

Phase 2 trial testing EPI-743 in Noise-induced Hearing Loss in 77 participants. Completed in 29 February 2016.

Timeline

31 October 2014

Primary endpoint
30 November 2015

29 February 2016

Quick facts

Lead sponsor	Edison Pharmaceuticals Inc
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	77
Start date	31 October 2014
Primary completion	30 November 2015
Estimated completion	29 February 2016
Sites	1 location across United States

Drugs / interventions tested

EPI-743 — full drug profile →
Placebo

Conditions studied

Noise-induced Hearing Loss — all drugs for Noise-induced Hearing Loss →

Sponsor

Edison Pharmaceuticals Inc — full company profile →

Who can join

Adults 18 to 30, any sex, with Noise-induced Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Noise-Induced Hearing Loss.
Natarajan N, Batts S, Stankovic KM. · · 2023 · cited 115× · PMID 36983347 · DOI 10.3390/jcm12062347
Investigational Medicinal Products for the Inner Ear: Review of Clinical Trial Characteristics in ClinicalTrials.gov.
Le Prell CG. · · 2021 · cited 18× · PMID 35609594 · DOI 10.1055/s-0041-1735522
Recent Therapeutic Progress and Future Perspectives for the Treatment of Hearing Loss.
Lye J, Delaney DS, Leith FK, Sardesai VS, et al · · 2023 · cited 16× · PMID 38137568 · DOI 10.3390/biomedicines11123347
Otoprotectants: From Research to Clinical Application.
Le Prell CG. · · 2019 · cited 16× · PMID 31036993 · DOI 10.1055/s-0039-1684045
Prevention of Noise-Induced Hearing Loss Using Investigational Medicines for the Inner Ear: Previous Trial Outcomes Should Inform Future Trial Design.
Le Prell CG. · · 2022 · cited 12× · PMID 34346254 · DOI 10.1089/ars.2021.0166
Evaluating the efficacy of vatiquinone in preclinical models of Leigh syndrome and GPX4 deficiency.
Kayser EB, Mulholland M, Olkhova EA, Chen Y, et al · · 2025 · cited 2× · PMID 39930437 · DOI 10.1186/s13023-025-03582-x

Verify or expand the search:

Other trials of EPI-743

Trials testing the same drug.

NCT02226458 — An Exploratory Open Label Study of EPI-743 (Vincerinone TM) in Children With Autism Spectrum Disorder · Phase 2 · withdrawn
NCT02104336 — Phase 2 Study of EPI-743 in Children With Pearson Syndrome · Phase 2 · terminated
NCT02352896 — Long-Term Safety and Efficacy Evaluation of EPI-743 in Children With Leigh Syndrome · Phase 2 · completed
NCT01642056 — EPI-743 for Metabolism or Mitochondrial Disorders · Phase 1, PHASE2 · completed
NCT01370447 — EPI-743 for Mitochondrial Respiratory Chain Diseases · no longer available

Other recruiting trials for Noise-induced Hearing Loss

Currently open trials in the same condition.

NCT06729632 — Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss · NA · recruiting

Other Edison Pharmaceuticals Inc trials

Trials by the same sponsor.

NCT02462603 — Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease · Phase 2 · completed
NCT02360436 — Analysis of the Glutathione Cycle in Children With Rett Syndrome · withdrawn
NCT02226458 — An Exploratory Open Label Study of EPI-743 (Vincerinone TM) in Children With Autism Spectrum Disorder · Phase 2 · withdrawn
NCT02104336 — Phase 2 Study of EPI-743 in Children With Pearson Syndrome · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02257983 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Edison Pharmaceuticals Inc
Last refreshed: 18 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02257983.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing